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Stellar Biotechnologies

Port Hueneme, California-based Stellar Biotechnologies has developed a technology platform of safe and effective carriers for therapeutic vaccines based on hemocyanin from the keyhole limpet, or KLH. Since FY2000, the company has been awarded more than $4 million in funding from the Small Business Innovation Research (SBIR) Programs to develop its technology.

According to Stellar CEO Frank Oakes, "Funding through the SBIR program was absolutely critical. It allowed the company to acquire the essential analytical tools we needed to evaluate our purification methods, and acquire manufacturing resources that are typically accessible only to major companies or university research centers. It also allowed us to expand Stellar's unique 'closed system' aquaculture of the keyhole limpet, Megathura crenulata, in a GMP (Good Manufacturing Practice) setting for production of clinical grade KLH. This platform has been pivotal in securing customers, partnerships and ultimately additional capital investment for business expansion."

Stellar's success also led to the company's merger to form a publically traded company on the TSX Venture Exchange (TSX-V) in Vancouver, Canada on April 20, 2010. As a result, Stellar was able to raise $8 million in funding through private placements. The company has since signed several contracts with pharmaceutical companies to provide the KLH carrier protein and has patents and FDA approvals pending for various pharmaceutical products and techniques.

Recent important partnerships include a marketing agreement for sales and distribution of high molecular weight KLH from Stellar's aquaculture production platform for the vaccine and adjuvant markets with SAFC, a unit of Sigma-Aldrich. Stellar also has a joint development agreement for integration of KLH manufacturing into Bayer's "plant made protein" expression platform for vaccine antigens with Bayer Innovations.

About the NCI-Supported Technologies

KLH is a protein that effectively stimulates the immune system response in humans, making it a valuable component of therapeutic vaccines and treatments for cancers, autoimmune diseases, chemical dependency, and other diseases. Though the surface molecules on cancer cells differ from those on normal, healthy cells, the immune system typically fails to recognize and attack the cancer cells because those cancer-specific molecules are too small. When KLH is attached to these cancer-specific molecules, its presence activates the immune system to mount a vigorous response, and potentially target and destroy cancer cells.

Five-year old Megathura crenulata produced by Stellar Biotechnologies. Photo by F. Oakes

KLH is derived from the hemolymph of the giant keyhole limpet, a large snail with a cone-shaped shell found only in the waters off the coast of Southern California. Unfortunately, the organism exists in very limited numbers. The discovery of clinical applications for the creature has led to concerns about potential overharvesting. According to Stellar, estimates indicate that demand for KLH could outpace the natural supply within the next seven years. As a result, the company has focused on developing methods for sustainable cultivation of the mollusk to ensure a continued source for biomedical research and vaccine development. Stellar has also pioneered a method of extracting KLH from live animals in an efficient and non-lethal manner. "Stellar ensures an economically viable, scalable, secure, and purified source of KLH," said Oakes.

Stellar has also developed various formulations of KLH to fit the growing needs of the market. One formulation of KLH, Stellar KLH SUBUNIT, is currently in clinical trials as a part of different therapeutic vaccines, including cancer vaccines. Another, Stellar High Molecular Weight (HMW or "Native") KLH is now available from SAFC and being sold for use in clinical trials for cancer. Stellar's KLH ASP is considered a "starter" KLH that can be engineered into other forms. All formulations have been demonstrated safe for human use and are currently available for purchase by pharmaceutical companies.

Stellar KLH HMW is a formulation capable of generating an even stronger immune response. As an effective immune system stimulant that promotes vaccine efficacy, it is also destined for use in testing patients for immune system deficiencies.

The cGMP-grade KLH HMW produced by SAFC will also be incorporated into Stellar's immunotoxicology diagnostic platform. Pharmaceutical companies have recently shown interest in using such diagnostic tests to evaluate consistency of purity amongst KLH formulations and to establish standardization of their immunotoxicology assays.

KLH Formulation

Stage

Use or potential use

Stellar KLH SUBUNIT

In clinical trials and available for sale

Component in vaccines

Stellar KLH ASP

Available for sale

"Starter" KLH that can be engineered into different forms

Stellar KLH HMW

Scheduled for clinical trial

• May promote vaccine efficacy
• May help to identify immune system deficiencies

cGMP-grade KLH HMW

Available from SAFC

• Potential use in immunotoxicology diagnostic platform

Advancing Cancer Research

While KLH is a key component of many types of vaccines, the most exciting opportunity is KLH's ability to stimulate development of cancer vaccines. This is due, in part, to its effectiveness in promoting an immune system response to cancer-specific molecules. Currently, several companies and institutions are developing KLH-based therapies for a wide variety of cancers. Examples include Optimer Pharmaceuticals, which is in phase II clinical trials with a breast cancer vaccine, Celldex Therapeutics, which is in phase II clinical trials with a glioblastoma vaccine, and Biovest International, which is evaluating a vaccine for non-Hodgkin lymphoma in phase IIIB trials.

"By giving academic researchers and private companies the assurance of a long-term, sustainable supply of a critical carrier protein," stated Oakes, "Stellar is facilitating oncology research." SBIR support allows small businesses like Stellar to develop technology that could change the landscape of cancer treatment.

More about the NCI SBIR & STTR Programs

For more information about how the NCI SBIR & STTR Programs can help your small business advance cancer research, treatment, and prevention, or to find out about upcoming funding opportunities, visit http://sbir.cancer.gov. To sign up to receive email updates from the NCI SBIR & STTR programs, contact us.

Disclaimer

Reference to any specific commercial products, process, service, manufacturer, and/or company does not constitute an endorsement or recommendation by the National Cancer Institute (NCI), the NCI's Small Business Innovation Research (SBIR) & Small Business Technology Transfer (STTR) Programs, or any other portion of the U.S. Government.